Liability and what we need to do

[ajlennon]

Spinning this out as a separate issue although it relates to #64 "Not charging" @afroleft @amcewen

• I've been speaking with 3DCrowd and the very clear advice they have received is that these splash visors are a Class 3 PPE not Class 1 PPE and as such it is irrelevant whether we charge for them or give them away. They must have CE approval, or as a minimum we must have sought CE approval.

• CE approval must be sought from a notified body which includes BSI or SGS.

• 3DCrowd are applying for approval for the Prusa design today. [Edit: 3DCrowd DO have to have received a response but that response is that it is in the review system (queue) not that the review body have approved it. The device can be supplied after the application is confirmed as in the queue]

• They want to add the DoES laser cut design into their approval application as they see the value of laser cutting

• For this to happen the design would be a variant of the DoES design with Prusa hole spacing so it fits with the visor shields they are having manufactured.

Clearly this doesn't affect anything in terms of the internal DoES workflow, excepting the liability concerns raised

• In addition Carwyn in North Wales is working with the Welsh Government to progress CE approval for Prusa. (He's chasing this and will let us know where they are up to)

• These approvals will also cover injection moulding processes which 3DCrowd are pursuing and I will be pursuing locally.

Also see: BLOG: HOW TO SAFELY SUPPLY HOMEMADE OR 3D PRINTED PPE FACE SHIELDS

[Edit - also from 3DCrowd: See EC recommendations Clause 11 of Visors and Covid]

[afroleft]

Looks like it’s heading in the right direction, Alex.

What’s next to get the application over the line?

[ajlennon]

• 3DCrowd want to work with us to get the Prusa hole spacing compliant variant of the DoES design approved
• It may also be possible to collaborate with the Welsh Government who are actively supporting seeking CE approvals for designs [Carwyn to update on current state of play]

[drakard]

If you were to provide 3DCrowd a Prusa compatible visor design, do you think there's any chance they could submit the original DoES version at the same time? They are almost the same, there might not be a lot of extra work. Given that there are already 2 widely used standards with parts being made, the certification organisation might see it as efficient to get an official design for both standards published together.

[JackiePease]

I agree with @drakard - worth investigating

[ajlennon]

@drakard For me the hand making of visors is a waste of time and money. Why make them when we can just get them shipped in and out. We should be standardising nationally on a pre-cut visor design not doing our own thing

[drakard]

@ajlennon ah if it's possible to standardise nationally that would be great

[ajlennon]

@ajlennon ah if it's possible to standardise nationally that would be great

It's happening now :)

[markmellors]

Excellent work here. Cambridge Makespace has found that many organisations are happy to accept non-CE-marked visors, but not all. we have the neccessary technical file but haven't pursued CE-marking yet. CE marking is usually required for anything that is put into service, not sold. and my understanding of the current relaxation is as you've described, the CE marking process must be in progress to be granted the easement.
One comment on wording, I think you mean Class 3 PPE, not a Class 3 Medical Device, as that's quite a different beast. Class III medical devices are the highest risk and most critical, such as implants or life support.
One challenge for 3dcrowd will be showing all produces are complying with the manufacturing SOP, or putting sufficient quality checks in place to confirm they have.

[ajlennon]

One comment on wording, I think you mean Class 3 PPE, not a Class 3 Medical Device, as that's quite a different beast. Class III medical devices are the highest risk and most critical, such as implants or life support.

Thanks - will make this change!

Feels to me that we are all beginning to align on SOP, designs etc. That feels like great progress in the right direction fwiw

[plastictactics]

Really good to see a common understanding developing here, and even more exciting to see organisations collaborating on getting visors approved.

[ajlennon]

@afroleft, @mjamjoum @amcewen there was a webinar today. Unfortunately I missed it but am trying to find a recording

http://page.bsigroup.com/PPE-Webinar-Email

From Cat Fitzgerald, "It was very clear on the call that face shields must have notified body involvement to ensure the safety of healthcare workers using them"

From Andrew Boucher "the BSI seems to have decided it is Cat 2 not Cat 3, the EU guidance states it is Cat 3 fairly specifically. 2-3 days turnaround. They said several times about the cottage industries (us) making visors that don't conform with the regs but the Prusa design does according to our experts. The Verkstadt clearly doesn't"

[ajlennon]

BSI Webinar Slides

via Cat Fitzpatrick
Slides from BSI webinar
• Cat II for face shields
• No category for scrubs (not PPE)
• Cat III for respiratory masks, gloves, gowns

https://helpfulengineering.slack.com/archives/C010KS87L2X/p1586945495200400?thread_ts=1586941140.195800&cid=C010KS87L2X